Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products-Recommended Practices; Availability, 33569-33572 [2014-13569]
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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Notices
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4—GUDID Submission and 21 CFR 11
Requirements
Appendix D—GUDID Attributes
Mapped to a Fictitious Medical
Device Label
Glossary
We are making available on the
Internet at the FDA/UDI Web site
(https://www.fda.gov/udi) updated
versions of two appendices of the draft
guidance: The section formerly
identified as ‘‘Appendix B’’, which
summarizes the device attribute
information that will populate the
GUDID, renamed as ‘‘GUDID Data
Elements Reference Table’’; and the
section formerly identified as
‘‘Appendix C’’, which summarizes the
UDI formats accepted by the issuing
agencies that FDA has accredited to
date, renamed as ‘‘UDI Formats by FDAAccredited Issuing Agency’’. These two
documents contain technical
specifications only, and we therefore are
not going to publish them as a part of
guidance that describes the Agency’s
interpretation of or policy on a
regulatory issue. For those without
Internet access or who otherwise would
like to receive a hard copy of the
currently updated version of either of
these documents, formerly published as
Appendix B and Appendix C of the
draft guidance, please call the Contact
Person (see FOR FURTHER INFORMATION
CONTACT) to request the document(s).
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking about the GUDID. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach for interfacing with
the GUIDID may be used with prior FDA
approval if such approach satisfies the
technical requirements of the GUDID
and the requirements of the applicable
statute and regulations. If you wish to
use an alternative approach for
submitting a specific required data
element, you may request FDA approval
by email or writing to: UDI Regulatory
Policy Support, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 3303,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, email: udi@
fda.hhs.gov (Attention: UDI Regulatory
Policy Support). If a labeler has a waiver
from electronic submission of GUDID
data under § 830.320(c) (21 CFR
830.320(c)), the labeler must send a
letter containing all of the information
otherwise required by this guidance, as
well as any permitted ancillary
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information that the labeler wishes to
submit, within the time permitted to:
UDI Regulatory Policy Support at the
address indicated in the previous
sentence. (See § 830.320(c)(3).)
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Global Unique Device Identification
Database (GUDID): Guidance for
Industry’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number 1831
to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
described in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
21 CFR part 830 pertaining to GUDID
labeler accounts and data submissions
addressed in this guidance document
has been approved under OMB control
number 0910–0720.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13568 Filed 6–10–14; 8:45 am]
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33569
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0758]
Draft Guidance for Industry on
Distributing Scientific and Medical
Publications on Risk Information for
Approved Prescription Drugs and
Biological Products—Recommended
Practices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Distributing Scientific and Medical
Publications on Risk Information for
Approved Prescription Drugs and
Biological Products—Recommended
Practices.’’ This guidance describes
FDA’s current thinking on
recommended practices for drug
manufacturers and their representatives
to follow when distributing to health
care professionals or health care entities
scientific or medical journal articles that
discuss new risk information for
approved prescription drugs for human
use, including drugs licensed as
biological products, and approved
animal drugs. The recommendations in
this draft guidance are intended to
address issues specific to the
distribution of new information about
risks associated with a drug that further
characterizes risks identified in the
approved labeling.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 25,
2014. Submit written comments on the
proposed collection of information by
August 11, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002; or to
Communications Staff (HFV–12), Center
SUMMARY:
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for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Lauren
Wedlake, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6328, Silver Spring,
MD 20993–0002, 301–796–2500.
Regarding prescription biological
products: Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
Regarding animal drugs: Dorothy
McAdams, Center for Veterinary
Medicine (HFV–216), 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6802.
SUPPLEMENTARY INFORMATION:
ehiers on DSK2VPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Distributing Scientific and Medical
Publications on Risk Information for
Approved Prescription Drugs and
Biological Products—Recommended
Practices.’’ In February 2014, FDA
issued a draft guidance entitled
‘‘Distributing Scientific and Medical
Publications on Unapproved New
Uses—Recommended Practices’’ to
clarify the Agency’s position on
manufacturer dissemination of scientific
or medical publications—including
scientific or medical journal articles,
scientific or medical reference texts, and
clinical practice guidelines—that
include information on unapproved
new uses of the manufacturer’s
products. Stakeholders have raised
questions regarding the Agency’s
position on manufacturer dissemination
of new scientific or medical information
about safety information contained in
the labeling for approved drugs. Because
this concerns dissemination of new risk
information related to approved uses of
a drug, this issue is distinct from the
dissemination of information on
unapproved new uses of approved
drugs. In response to those questions,
the Agency is issuing this draft guidance
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to clarify and solicit public comments
on the Agency’s position on
manufacturer dissemination of new risk
information regarding lawfully
marketed drugs for approved uses to
health care professionals or health care
entities.
FDA recognizes that the safety profile
of a drug evolves throughout its
lifecycle as the extent of exposure to the
product increases and that it can be
helpful for health care practitioners to
receive significant new risk information
about an approved product in a timely
manner. FDA anticipates that the
earliest distribution of new risk
information will generally involve
distribution of recently published
studies, as opposed to textbooks or
clinical practice guidelines.
Accordingly, FDA is providing guidance
for manufacturers that choose to
distribute new risk information in the
form of a reprint or digital copy of a
published study.
FDA believes that recommendations
specific to the distribution of risk
information are needed for two reasons:
• In general, there are differences in
the purpose, nature, and reliability of
the evidence used to determine the
effectiveness of a drug (e.g., to support
a new intended use) and the evidence
that is the basis for a product’s risk
assessment. Therefore, FDA believes
guidance is needed to address the
spectrum of data sources that could be
appropriate for distribution to provide
new risk information.
• New risk information may
contradict or otherwise deviate from the
risk information in the approved
labeling, which may cause confusion or
otherwise contribute to patient harm. If
the new information is unreliable or
presented without the appropriate
context, it could influence prescribing
decisions or patient monitoring in a
manner that could harm patients.
Therefore, FDA is proposing
recommendations for study or analysis
and distribution criteria to help ensure
that new risk information that rebuts,
mitigates, or refines risk information in
approved labeling meets appropriate
standards for reliability and is presented
with appropriate disclosure of its
limitations.
The guidance is being issued in draft
to enable public comment on the
proposed recommendations.
In light of emerging case law, in
particular the case law involving the
First and Fifth Amendments of the
United States Constitution, FDA is
currently engaged in a comprehensive
review of its regulations and guidance
documents in an effort to harmonize the
fundamental public health interests
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underlying FDA’s mission and statutory
framework with interests in the
dissemination of truthful and nonmisleading information. This draft
guidance on distribution of risk
information about approved
prescription drugs and biological
products is a part of that effort. This
draft guidance does not address medical
devices. FDA also plans to issue, by the
end of the calendar year, additional
guidance that addresses manufacturer
responses to unsolicited requests,
distributing scientific and medical
information on unapproved new uses,
manufacturer discussions regarding
scientific information more generally,
and distribution of health care economic
information to formulary committees
and similar entities.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Distributing Scientific and Medical
Publications on Risk Information for
Approved Prescription Drugs and
Biological Products—Recommended
Practices.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Notices
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information collected;
and (4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Recommendations for
Distributing Scientific and Medical
Publications on Risk Information for
Approved Prescription Drugs and
Biological Products.
Description of Respondents:
Respondents to this collection of
information are manufacturers of
approved prescription drugs for human
use, including drugs licensed as
biological products, and approved
animal drugs, and their representatives
(firms).
Burden Estimate: The draft guidance
pertains to the distribution, by firms, of
scientific and medical publications that
discuss new risk information for
approved prescription drugs for human
use and approved animal drugs
(including prescription, nonprescription, and Veterinary Feed
Directive drugs) marketed in the United
States. The draft guidance recommends
that if firms choose to distribute
scientific and medical publications
reflecting new risk information, those
publications should have certain
characteristics and certain other
information should be distributed with
them. Accordingly, the guidance
recommends a ‘‘third-party disclosure’’
that constitutes a ‘‘collection of
information’’ under the PRA.
If firms choose to distribute new risk
information that rebuts, mitigates, or
refines risk information in the approved
labeling, and the information is in the
form of a reprint or digital copy of a
published study, the guidance provides
recommendations regarding the
characteristics of those publications.
Specifically, with respect to the data
source:
• The study or analysis should meet
accepted design and other methodologic
standards for the type of study or
analysis (e.g., provides a clear
description of the hypothesis tested,
acknowledges and accounts for
potential bias and multiplicity) and
should be sufficiently well-designed
and informative to merit consideration
in assessing the implications of a risk.
• To rebut a prior determination
(reflected in the approved labeling) that
there is some basis to believe there is
causal relationship between the drug
and the occurrence of an adverse event,
or to otherwise mitigate a described risk,
the study or analysis should also be at
least as persuasive as the data sources
that underlie the existing risk
assessment of causality, severity, and/or
incidence of the adverse reaction as
reflected in approved labeling (e.g., data
from a new controlled trial designed to
estimate the relative risk of the event, a
pharmacoepidemiologic study that is
capable of reliably estimating the
relative risk, or a rigorous meta-analysis
of all relevant data from new and
existing controlled trials).
• The conclusions of the study or
analysis should give appropriate weight
and consideration to, and should be a
fair characterization of, all relevant
information in the safety database,
including contrary or otherwise
inconsistent findings. There is a broad
spectrum of potential data sources that
can contribute in some way to
characterization of a product’s safety;
new risk information should be
considered in light of all relevant
existing information and integrated with
that data to the extent possible.
• The study or analysis should be
published in an independent, peerreviewed journal.
The draft guidance also makes
recommendations with respect to the
distribution of the reprint or digital
copy, including the recommendation
that a cover sheet accompany the reprint
or digital copy that clearly and
prominently discloses the following:
• The study design, critical findings,
and significant methodologic or other
limitations of the study or analysis that
may limit the persuasiveness or scope of
findings that rebut, mitigate, or refine
risk information in the approved
labeling. Limitations should be
discussed in relation to the specific
circumstances of the study and its
conclusions about a risk.
• The information is not consistent
with certain risk information in the
approved labeling (should specifically
identify the inconsistent information).
• FDA has not reviewed the data.
• Any financial interests or
affiliations between the study author(s)
and the firm.
The reprint or digital copy should be
accompanied by the approved labeling
for the product, and when distributed,
should be separate from any
promotional material. Any statements
made by a representative of the firm to
a recipient concerning the reprint
should be consistent with its content
and the information in the disclosure
cover sheet.
Additionally, FDA notes in the draft
guidance that the recommendations in
the guidance do not change a firm’s
existing obligations to revise its
approved labeling in accordance with
21 CFR 201.56(a)(2), 314.70, 514.8(c)
and 601.12. As described in this section
of the document, this recommendation
refers to previously approved
collections of information found in FDA
regulations. FDA estimates that
approximately 500 firms annually
distribute scientific and medical
publications that discuss new risk
information for approved prescription
drugs. FDA also estimates that each firm
would include some or all of the
additional information described
previously when distributing annually a
total of approximately 4,250 scientific or
medical journal articles that discuss
new risk information for approved
prescription drugs. FDA estimates that it
will take each firm approximately 16
hours to make the disclosures
recommended in this draft guidance,
which includes the time needed to
determine whether the article complies
with the guidance recommendation on
the characteristics of the scientific and
medical publications that companies
distribute, to determine financial
conflicts of interest, to prepare the
disclosure statements, and to attach the
product labeling.
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TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Draft guidance on distributing scientific and medical publications on risk information for approved prescription drugs
and biological products—recommended practices
Number of
respondents
Distribution of scientific and medical publications on risk
information ........................................................................
1 There
Number of
disclosures
per
respondent
500
Total annual
disclosures
8.5
4,250
are no capital costs or operating and maintenance costs associated with this collection of information.
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Average
burden per
disclosure
16
Total hours
68,000
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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Notices
This draft guidance also refers to
previously approved collections of
information found in FDA regulations
with respect to submitting supplements
to approved applications. These
collections of information are subject to
review by OMB under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3502). The collection of information in
21 CFR 201.56(a)(2) has been approved
under OMB control number 0910–0572;
in 21 CFR 314.70 has been approved
under OMB control number 0910–0001;
in 21 CFR 601.12 has been approved
under OMB control number 0910–0338;
and in 21 CFR 514.8(c) has been
approved under OMB control number
0910–0032.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
https://www.regulations.gov.
Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13569 Filed 6–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ehiers on DSK2VPTVN1PROD with NOTICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
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Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: July 9, 2014, 8:30
a.m.–5:30 p.m., July 10, 2014, 8:30 a.m.–
3:30 p.m.
Place: To be determined. (The most
current information, including the
agenda, will be posted at: https://
www.hrsa.gov/advisorycommittees/
mchbadvisory/InfantMortality/
index.html).
Status: The meeting is open to the
public with attendance limited to space
availability.
Purpose: The Committee provides
advice and recommendations to the
Secretary of Health and Human Services
on the following: Department of Health
and Human Services’ programs that
focus on reducing infant mortality and
improving the health status of infants
and pregnant women and factors
affecting the continuum of care with
respect to maternal and child health
care. It includes outcomes following
childbirth; strategies to coordinate
myriad federal, state, local, and private
programs and efforts that are designed
to deal with the health and social
problems impacting on infant mortality;
and the implementation of the Healthy
Start Program and Healthy People 2020
infant mortality objectives.
Agenda: Topics that will be discussed
include the following: Health Resources
and Services Administration (HRSA)
Update; MCHB Update; Healthy Start
Program Update; Updates from
Partnering Agencies and Organizations;
and ACIM’s recommendations for the
HHS National Strategy to Address Infant
Mortality, specifically Strategy 2: The
continuum of high-quality, patientcentered care.
Proposed agenda items are subject to
change as priorities dictate. Time will
be provided for public comments
limited to 5 minutes each. Comments
are to be submitted in writing no later
than 5 p.m. ET on July 1, 2014.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the Committee should contact Michael
C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration, Room 18 W,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301)
443–2170. Individuals who are
submitting public comments or who
have questions regarding the meeting
and location should contact David S. de
la Cruz, Ph.D., M.P.H., ACIM Designated
Federal Official, Health Resources and
Services Administration, Maternal and
Child Health Bureau, Telephone: (301)
443–0543, email: David.delaCruz@
hrsa.hhs.gov.
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Dated: June 4, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–13527 Filed 6–10–14; 8:45 am]
BILLING CODE
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2014–0154]
Information Collection Request to
Office of Management and Budget
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICRs) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting
approval of a revision to the following
collection of information: 1625–0005,
Application and Permit to Handle
Hazardous Materials. Our ICR describes
the information we seek to collect from
the public. Before submitting this ICR to
OIRA, the Coast Guard is inviting
comments as described below.
DATES: Comments must reach the Coast
Guard on or before August 11, 2014.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2014–0154] to the
Docket Management Facility (DMF) at
the U.S. Department of Transportation
(DOT). To avoid duplicate submissions,
please use only one of the following
means:
(1) Online: https://
www.regulations.gov.
(2) Mail: DMF (M–30), DOT, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001.
(3) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
(4) Fax: 202–493–2251. To ensure
your comments are received in a timely
manner, mark the fax, to attention Desk
Officer for the Coast Guard.
The DMF maintains the public docket
for this Notice. Comments and material
received from the public, as well as
documents mentioned in this Notice as
being available in the docket, will
become part of the docket and will be
available for inspection or copying at
SUMMARY:
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[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33569-33572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13569]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0758]
Draft Guidance for Industry on Distributing Scientific and
Medical Publications on Risk Information for Approved Prescription
Drugs and Biological Products--Recommended Practices; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Distributing Scientific and Medical Publications on Risk Information
for Approved Prescription Drugs and Biological Products--Recommended
Practices.'' This guidance describes FDA's current thinking on
recommended practices for drug manufacturers and their representatives
to follow when distributing to health care professionals or health care
entities scientific or medical journal articles that discuss new risk
information for approved prescription drugs for human use, including
drugs licensed as biological products, and approved animal drugs. The
recommendations in this draft guidance are intended to address issues
specific to the distribution of new information about risks associated
with a drug that further characterizes risks identified in the approved
labeling.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 25, 2014. Submit written comments on the proposed
collection of information by August 11, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002;
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or to
Communications Staff (HFV-12), Center
[[Page 33570]]
for Veterinary Medicine, Food and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Lauren Wedlake, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6328, Silver Spring, MD 20993-0002, 301-
796-2500.
Regarding prescription biological products: Stephen Ripley, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911.
Regarding animal drugs: Dorothy McAdams, Center for Veterinary
Medicine (HFV-216), 7519 Standish Pl., Rockville, MD 20855, 240-453-
6802.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Distributing Scientific and Medical Publications on Risk
Information for Approved Prescription Drugs and Biological Products--
Recommended Practices.'' In February 2014, FDA issued a draft guidance
entitled ``Distributing Scientific and Medical Publications on
Unapproved New Uses--Recommended Practices'' to clarify the Agency's
position on manufacturer dissemination of scientific or medical
publications--including scientific or medical journal articles,
scientific or medical reference texts, and clinical practice
guidelines--that include information on unapproved new uses of the
manufacturer's products. Stakeholders have raised questions regarding
the Agency's position on manufacturer dissemination of new scientific
or medical information about safety information contained in the
labeling for approved drugs. Because this concerns dissemination of new
risk information related to approved uses of a drug, this issue is
distinct from the dissemination of information on unapproved new uses
of approved drugs. In response to those questions, the Agency is
issuing this draft guidance to clarify and solicit public comments on
the Agency's position on manufacturer dissemination of new risk
information regarding lawfully marketed drugs for approved uses to
health care professionals or health care entities.
FDA recognizes that the safety profile of a drug evolves throughout
its lifecycle as the extent of exposure to the product increases and
that it can be helpful for health care practitioners to receive
significant new risk information about an approved product in a timely
manner. FDA anticipates that the earliest distribution of new risk
information will generally involve distribution of recently published
studies, as opposed to textbooks or clinical practice guidelines.
Accordingly, FDA is providing guidance for manufacturers that choose to
distribute new risk information in the form of a reprint or digital
copy of a published study.
FDA believes that recommendations specific to the distribution of
risk information are needed for two reasons:
In general, there are differences in the purpose, nature,
and reliability of the evidence used to determine the effectiveness of
a drug (e.g., to support a new intended use) and the evidence that is
the basis for a product's risk assessment. Therefore, FDA believes
guidance is needed to address the spectrum of data sources that could
be appropriate for distribution to provide new risk information.
New risk information may contradict or otherwise deviate
from the risk information in the approved labeling, which may cause
confusion or otherwise contribute to patient harm. If the new
information is unreliable or presented without the appropriate context,
it could influence prescribing decisions or patient monitoring in a
manner that could harm patients. Therefore, FDA is proposing
recommendations for study or analysis and distribution criteria to help
ensure that new risk information that rebuts, mitigates, or refines
risk information in approved labeling meets appropriate standards for
reliability and is presented with appropriate disclosure of its
limitations.
The guidance is being issued in draft to enable public comment on
the proposed recommendations.
In light of emerging case law, in particular the case law involving
the First and Fifth Amendments of the United States Constitution, FDA
is currently engaged in a comprehensive review of its regulations and
guidance documents in an effort to harmonize the fundamental public
health interests underlying FDA's mission and statutory framework with
interests in the dissemination of truthful and non-misleading
information. This draft guidance on distribution of risk information
about approved prescription drugs and biological products is a part of
that effort. This draft guidance does not address medical devices. FDA
also plans to issue, by the end of the calendar year, additional
guidance that addresses manufacturer responses to unsolicited requests,
distributing scientific and medical information on unapproved new uses,
manufacturer discussions regarding scientific information more
generally, and distribution of health care economic information to
formulary committees and similar entities.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
``Distributing Scientific and Medical Publications on Risk Information
for Approved Prescription Drugs and Biological Products--Recommended
Practices.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document. This
draft guidance also refers to previously approved collections of
information found in FDA regulations.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed information
collected is necessary for the proper performance of FDA's functions,
including whether the
[[Page 33571]]
information will have practical utility; (2) the accuracy of FDA's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information
collected; and (4) ways to minimize the burden of information collected
on the respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Recommendations for Distributing Scientific and Medical
Publications on Risk Information for Approved Prescription Drugs and
Biological Products.
Description of Respondents: Respondents to this collection of
information are manufacturers of approved prescription drugs for human
use, including drugs licensed as biological products, and approved
animal drugs, and their representatives (firms).
Burden Estimate: The draft guidance pertains to the distribution,
by firms, of scientific and medical publications that discuss new risk
information for approved prescription drugs for human use and approved
animal drugs (including prescription, non-prescription, and Veterinary
Feed Directive drugs) marketed in the United States. The draft guidance
recommends that if firms choose to distribute scientific and medical
publications reflecting new risk information, those publications should
have certain characteristics and certain other information should be
distributed with them. Accordingly, the guidance recommends a ``third-
party disclosure'' that constitutes a ``collection of information''
under the PRA.
If firms choose to distribute new risk information that rebuts,
mitigates, or refines risk information in the approved labeling, and
the information is in the form of a reprint or digital copy of a
published study, the guidance provides recommendations regarding the
characteristics of those publications. Specifically, with respect to
the data source:
The study or analysis should meet accepted design and
other methodologic standards for the type of study or analysis (e.g.,
provides a clear description of the hypothesis tested, acknowledges and
accounts for potential bias and multiplicity) and should be
sufficiently well-designed and informative to merit consideration in
assessing the implications of a risk.
To rebut a prior determination (reflected in the approved
labeling) that there is some basis to believe there is causal
relationship between the drug and the occurrence of an adverse event,
or to otherwise mitigate a described risk, the study or analysis should
also be at least as persuasive as the data sources that underlie the
existing risk assessment of causality, severity, and/or incidence of
the adverse reaction as reflected in approved labeling (e.g., data from
a new controlled trial designed to estimate the relative risk of the
event, a pharmacoepidemiologic study that is capable of reliably
estimating the relative risk, or a rigorous meta-analysis of all
relevant data from new and existing controlled trials).
The conclusions of the study or analysis should give
appropriate weight and consideration to, and should be a fair
characterization of, all relevant information in the safety database,
including contrary or otherwise inconsistent findings. There is a broad
spectrum of potential data sources that can contribute in some way to
characterization of a product's safety; new risk information should be
considered in light of all relevant existing information and integrated
with that data to the extent possible.
The study or analysis should be published in an
independent, peer-reviewed journal.
The draft guidance also makes recommendations with respect to the
distribution of the reprint or digital copy, including the
recommendation that a cover sheet accompany the reprint or digital copy
that clearly and prominently discloses the following:
The study design, critical findings, and significant
methodologic or other limitations of the study or analysis that may
limit the persuasiveness or scope of findings that rebut, mitigate, or
refine risk information in the approved labeling. Limitations should be
discussed in relation to the specific circumstances of the study and
its conclusions about a risk.
The information is not consistent with certain risk
information in the approved labeling (should specifically identify the
inconsistent information).
FDA has not reviewed the data.
Any financial interests or affiliations between the study
author(s) and the firm.
The reprint or digital copy should be accompanied by the approved
labeling for the product, and when distributed, should be separate from
any promotional material. Any statements made by a representative of
the firm to a recipient concerning the reprint should be consistent
with its content and the information in the disclosure cover sheet.
Additionally, FDA notes in the draft guidance that the
recommendations in the guidance do not change a firm's existing
obligations to revise its approved labeling in accordance with 21 CFR
201.56(a)(2), 314.70, 514.8(c) and 601.12. As described in this section
of the document, this recommendation refers to previously approved
collections of information found in FDA regulations. FDA estimates that
approximately 500 firms annually distribute scientific and medical
publications that discuss new risk information for approved
prescription drugs. FDA also estimates that each firm would include
some or all of the additional information described previously when
distributing annually a total of approximately 4,250 scientific or
medical journal articles that discuss new risk information for approved
prescription drugs. FDA estimates that it will take each firm
approximately 16 hours to make the disclosures recommended in this
draft guidance, which includes the time needed to determine whether the
article complies with the guidance recommendation on the
characteristics of the scientific and medical publications that
companies distribute, to determine financial conflicts of interest, to
prepare the disclosure statements, and to attach the product labeling.
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Draft guidance on distributing
scientific and medical
publications on risk information Number of Number of Total annual Average burden
for approved prescription drugs respondents disclosures disclosures per disclosure Total hours
and biological products-- per respondent
recommended practices
----------------------------------------------------------------------------------------------------------------
Distribution of scientific and 500 8.5 4,250 16 68,000
medical publications on risk
information....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 33572]]
This draft guidance also refers to previously approved collections
of information found in FDA regulations with respect to submitting
supplements to approved applications. These collections of information
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3502). The collection of information in 21 CFR
201.56(a)(2) has been approved under OMB control number 0910-0572; in
21 CFR 314.70 has been approved under OMB control number 0910-0001; in
21 CFR 601.12 has been approved under OMB control number 0910-0338; and
in 21 CFR 514.8(c) has been approved under OMB control number 0910-
0032.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.
Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13569 Filed 6-10-14; 8:45 am]
BILLING CODE 4164-01-P
